The phase 2 NADIM II aimed to determine the most appropriate treatment for patients with resectable stage III non-small-cell lung cancer (NSCLC). Patients were randomly assigned to receive either neoadjuvant nivolumab plus platinum-based chemotherapy followed by surgery (experimental group) or chemotherapy alone followed by surgery (control group). Patients in the experimental group who underwent successful surgery received adjuvant treatment with nivolumab. The primary endpoint was a pathological complete response. Secondary endpoints included progression-free survival, overall survival at 24 months, and safety. Results showed that the experimental group had a higher percentage of patients with a pathological complete response compared to the control group (37% vs. 7%). Surgery was also performed in a higher proportion of patients in the experimental group. Kaplan-Meier estimates demonstrated better progression-free survival and overall survival at 24 months in the experimental group compared to the control group. Adverse events of grade 3 or 4 occurred in both groups but were slightly more frequent in the experimental group.

The study concludes that perioperative treatment with nivolumab plus chemotherapy improved pathological response and survival outcomes in patients with resectable stage III NSCLC compared to chemotherapy alone.

https://www.nejm.org/doi/full/10.1056/NEJMoa2215530